Problems and measures in the management of clinical trial drugs in an organization
Objective To improve the management level of clinical trial drugs and ensure the quality of clinical trials.Methods The results of quality control on the management of clinical trial drugs of 32 research projects undertaken by an organization from March 2021 to July 2023 were collected,and the problems were summarized and analyzed,and improvement measures and suggestions were put forward.Results The total number of unqualified items was 25,totaling 57 problems.By summarizing and analyzing the questions in each link,the reasons for irregularities in the management of clinical trial drugs were found in personnel,management,software and hardware.Improvement measures were proposed to improve the management process of clinical trial drugs,enhance the operability of the SOP and management system of clinical trial drugs,strengthen the training of research personnel,strengthen the medication education of subjects,establish the information management system of clinical trial drugs,and carry out regular quality management of clinical trial drugs.Conclusion Clinical drug trial institutions should strengthen the management and training of trial drugs,establish a GCP central pharmacy,equip full-time pharmacists,improve the management level of trial drugs,and ensure that the drug clinical trial process is authentic and standardized,and the results are scientific and reliable.
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